Study of Having a Female Friend as Labor Support

August 22, 2005 updated by: Saint Peters University Hospital

Evaluation of Continuous Support in Labor

The purpose of this study was to compare labor outcomes in women accompanied by an additional support person (doula group) with outcomes in women who did not have this additional support person (control group).

The current study was designed with the benefits of continuous labor support in mind as well as the need for a cost-effective, affordable program to provide those services for low-income women. Its purpose was to evaluate the effects of continuous labor support provided by a female companion of the pregnant person's choosing who, with the mother, had participated in an educational program to teach her how to provide continuous labor support.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study was to evaluate the influence of a female companion in labor who had been chosen by a nulliparous, underinsured, low-income woman and who had received brief training in supportive labor techniques. The objective was to compare labor outcomes, specifically cesarean section rates, in women accompanied by this additional support person (doula group) with outcomes in women who did not have this additional support person (control group).

Study Type

Interventional

Enrollment

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 07109
        • Saint Peters University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Nulliparous (never given birth before)
  • Singleton pregnancy
  • Vertex presentation
  • Low risk pregnancy
  • Has a female friend willing to be a doula

Exclusion Criteria:

  • Placenta previa
  • Abruptio placenta
  • Multiple pregnancy
  • Breech presentation
  • Planned operative delivery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Length of labor
type of delivery
type and timing of analgesia/anesthesia

Secondary Outcome Measures

Outcome Measure
Birthweight
neonatal Apgar score at 1 and 5 minutes after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Peters University Hospital

Investigators

  • Principal Investigator: Della A Campbell, PhDc, Saint Peters University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1998

Study Completion

February 1, 2003

Study Registration Dates

First Submitted

August 4, 2005

First Submitted That Met QC Criteria

August 4, 2005

First Posted (Estimate)

August 5, 2005

Study Record Updates

Last Update Posted (Estimate)

August 23, 2005

Last Update Submitted That Met QC Criteria

August 22, 2005

Last Verified

April 1, 2005

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DAC-1998

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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